Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Single Marketing Application Review For Multiple Jurisdictions On Horizon

Executive Summary

Medical device makers could get their products to markets around the world faster if plans for a single premarket review program by international regulators go ahead.

You may also be interested in...



If You Build It, Will They Come? Vital That UK MHRA Creates Right Environment For Medtechs

The Medicines and Medical Devices Act presses the UK to regulate in such a way that makes the market attractive for industry and investment. Medtech manufacturers insist the MHRA must strike the right balance as it brings its ‘plan for a new agency’ to life, said the ABHI’s Phil Brown, in the second of a two-part industry view of UK medtech’s regulatory future.

Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot

FDA hopes the Accreditation Scheme for Conformity Assessment pilot will make it easier to trust the declarations of conformity to standards that are made by device-makers in pre-market submissions, rather than having to ask a lot of time-consuming questions. ASCA, included in the latest FDA user-fee agreement, also has important implications for the agency's global harmonization efforts. But many questions remain about its value and viability; they were on display at a recent two-day workshop at the agency's headquarters.

User-Fee Facts: 10 Key Medtech Details From US FDA Agreements

While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT104694

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel